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Clinical Trials in the USA / NCT07673627
Recruiting Phase 2

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

NCT07673627 · tracked via the Priya Life Science USA tracker
Sponsor
argenx
Phase
Phase 2
Started
2026-07-10
Last updated
2026-10-16

Condition(s) studied

AChR-Ab Seropositive Generalized Myasthenia GravisMyasthenia Gravis (MG)MG - Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Empasiprubart IV →Placebo IVEfgartigimod PH20 SC PFS

Empasiprubart IV: Intravenous infusions of empasiprubart

Placebo IV: Intravenous infusions of placebo

Efgartigimod PH20 SC PFS: Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

Study summary

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

The aim of this ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).

The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

More information can be found here: https://clinicaltrials.argenx.com/adaptforward2

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab). * Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb. * Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years before ISA screening or will complete immunization at least 14 days before the first IMP administration. Exclusion Criteria: * Clinical diagnosis of systemic lupus erythematosus (SLE). * Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab \>2 months or ravulizumab \>6 months before baseline are allowed to participate. * Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline. * Had prior empasiprubart exposure.

Primary outcome measure(s)

  • Incidence of adverse events and serious adverse events in the DBTP — Up to 12 weeks

Trial sites (8)

FacilityCityRegionStatus
Neurology Center of Southern California Carlsbad California Recruiting
Visionary Investigators Network Miami Florida Recruiting
Profound Research LLC at Las Vegas Neurology Center Las Vegas Nevada Recruiting
Dent Neurologic Institute - Amherst Amherst New York Recruiting
Erlanger Health System Chattanooga Tennessee Recruiting
National Neuromuscular Research Institute Austin Texas Recruiting
AHEPA University General Hospital of Thessaloniki Thessaloniki Thessaloniki Recruiting
Hospital Regional Universitario de Malaga - Hospital General Málaga Malaga Recruiting

More argenx trials in the USA

A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) Active, not recruiting
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults Starting soon
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis Active, not recruiting
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Active, not recruiting
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Active, not recruiting

Other trials for the same condition

PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis Recruiting
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis Recruiting
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab Recruiting
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod Recruiting
Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07673627 on ClinicalTrials.gov ↗ ← All trials in the USA